A Food and Drug Administration advisory panel suggested Tuesday that the agency improve how it regulates pulse oximeters, calling for clearer labeling and more rigorous testing of the devices. The ...

Why are we asking for donations? Why are we asking for donations? This site is free thanks to our community of supporters. Voluntary donations from readers like you keep our news accessible for ...

The Google Home app is getting an update with a home panel that allows users to better monitor home devices. This comes after Google announced the public rollout of the revamped version of its app.

Given the lack of information on their effectiveness and the unreasonable risks for illness or injury, spinal sphere devices should be regulated as Class 3 devices that require premarket approval (PMA ...

The FDA’s Gastroenterology-Urology Devices Panel voted unanimously that LINX’s Reflux Management System, a laparoscopically implanted device designed to treat gastroesophageal reflux disease, has a ...

Johnson & Johnson’s billion-dollar bet on a novel implant for heart failure hit a roadblock this week, with an FDA advisory panel unanimously voting against its risk-benefit profile. The V-Wave ...

Please provide your email address to receive an email when new articles are posted on . An FDA panel voted that for adults with uncontrolled hypertension, the benefits of an ultrasound renal ...

Medtronic suffered a regulatory and competitive setback Wednesday after a U.S. Food and Drug Administration advisory panel expressed concerns about Symplicity Spyral, a device to treat hypertension.